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NCT Number: NCT04595032

MAnagement of METastatic Disease in Campania (MAMETIC)

The MAMETIC Trial represents the first regional epidemiological study that aims to evaluate patients living in Campania with metastatic cancer, with the intent to detect different prevalence of tumors in the metastatic phase and evaluate the local response to the patient's request for assistance.

Condition or disease: Metastatic disease Intervention/treatment: Radiation Treatment

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Key information

Conditions

Metastatic Disease Cancer Pain Neoplasm Metastasis Neoplasms Neoplastic Processes Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radioterapia Oncologica INT IRCCS- Fondazione G.Pascale Sede Centrale

Naples, Campania, Italy

About this study

The MAMETIC Trial is a multicenter, retrospective and prospective observational study and 17 of 20 RT Centers in Campania joined it.

  • The retrospective part of the study concerns all patients enrolled with a diagnosis of metastatic disease and treated in RT centers of the Campania Region with 3DCRT, IMRT, VMAT, SBRT techniques from January 2019 to August 2020. In 2019, it has been enrolled 12.500 patients in the 17 RT Centers and it is estimated that 20-30% of the above mentioned patients had metastasis. Thus, approximately 2.560 patients are expected to be enrolled.
  • The prospective part of the study is going to enroll all metastatic patients eligible for palliative RT, treated in RT Centers of the Campania region with 3DCRT, IMRT, VMAT, SBRT techniques from September 2020 to September 2025. Considering the RT Centers that joined the trial, it is expected to enroll approximately 2.500-4.200 patients per year and a total of 12.500-21.000 patients in 5 years.

The study will last 61 months, divided as follow: 60 months of enrollment phase and up to 1 month of follow-up for pain and bone metastasis patients. Follow-up will be performed on the 15th and 30th day after the end of radiation treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged > 18 years resident in Campania Region;
  • Patients diagnosed with metastatic disease candidates for radiotherapy
  • Metastatic patients candidates for radiotherapy re-treatment
  • Oligometastatic patients candidates for radiotherapy; Patients who have given their consent

Exclusion criteria

  • Patients aged < 18 years
  • Patients who are unable to express consent to sensitive data and radiant treatment

Treatment and study plan

3DCRT, IMRT, VMAT, SBRT

Device

Radiation treatment

Primary outcomes

  1. Retrospective Study: Occurrence of palliative radiotherapy treatments in the Campania region

    Time frame: 20 months (Interval from January 2019 to August 2020)

    Occurrence of palliative radiotherapy treatments in the Campania region (Epidemiological Study)

  2. Prospective Study: Occurrence of palliative radiotherapy treatments in the Campania region

    Time frame: 60 months (Interval from September 2020 to September 2025)

    Occurrence of palliative radiotherapy treatments in the Campania region (Epidemiological study)

Secondary outcomes

  1. Retrospective Study: a. Incidence of metastatic disease at diagnosis

    Time frame: 20 months (Interval from January 2019 to August 2020)

    Incidence of metastatic disease at diagnosis

  2. Retrospective Study: b. Time between first diagnosis and the onset of metastases

    Time frame: 20 months (Interval from January 2019 to August 2020)

    Time between first diagnosis and the onset of metastases

  3. Prospective Study: Level A a. Incidence of metastatic disease at diagnosis

    Time frame: 60 months (Interval from September 2020 to September 2025)

    Incidence of metastatic disease at diagnosis

  4. Prospective Study: Level A b. Time between first diagnosis and the onset of metastases

    Time frame: 60 months (Interval from September 2020 to September 2025)

    Time between first diagnosis and the onset of metastases

  5. Prospective Study: Level A c. Interval from the first course of the radiation therapy to the retreatment

    Time frame: 60 months (Interval from September 2020 to September 2025)

    Interval from the first course of the radiation therapy to the retreatment (Epidemiological study)

  6. Prospective Study: Level B a. Pain control

    Time frame: Up to 1 month after the end of RT

    Pain control measured for patient self-reporting of pain with Numeric Rating Scale (NRS) score, a 11-point scale (from 0 to 10), with higher scores indicating greater pain intensity

  7. Prospective Study: Level C a. Quality of Life (QoL) according to European Organization for Research and Treatment of Cancer (EORTC) QLQ-C15-PAL questionnaire (health-related quality of life).

    Time frame: Until 2 weeks before RT

    Quality of life (QoL) according to European Organization for Research and Treatment of Cancer (EORTC) QLQ-C15-PAL questionnaire (health-related quality of life). It is scored on a metric from 0 to 10, higher scores mean better outcome

  8. Prospective Study: Level C b. Functional performance measured by Palliative Performance Score (PPS).

    Time frame: Until 2 weeks before RT

    Functional performance measured by Palliative Performance Score (PPS). To score, there are 11 levels of PPS from 0% to 100% in 10 percent increments. Every decrease in 10% marks a fairly significant decrease in physical function.

  9. Prospective Study: Level C c. Quality of life (QoL) of patients with bone metastases according to European Organization for Research and Treatment of Cancer (EORTC) QLQ-BM22 questionnaire (health-related quality of life).

    Time frame: Until 2 weeks before RT

    Quality of life (QoL) of patients with bone metastases according to European Organization for Research and Treatment of Cancer (EORTC) QLQ-BM22 questionnaire (health-related quality of life). It is scored on a metric from 0 to 100. Higher scores mean better outcome.

  10. Prospective study: LEVEL C d. Incidence of spinal instability in patients with spinal metastases according to Spinal Instability Neoplastic Score (SINS)

    Time frame: Until 2 weeks before RT

    Incidence of spinal instability in patients with spinal metastases according to Spinal Instability Neoplastic Score (SINS). It is scored from 0 to 18. Higher scores mean worse outcome.

  11. Prospective study: LEVEL C e. Evaluation of functional impairment as a result of their spinal cord injury according to the American Spinal Injury Association (ASIA) Score.

    Time frame: Until 2 weeks before RT

    Evaluation of functional impairment as a result of their spinal cord injury according to the American Spinal Injury Association (ASIA) Score. It is scored from 0 to 324. Higher scores mean better outcome.

  12. Prospective study: LEVEL C f. Assessment of cognitive function in patients with brain metastases by Mini-Mental State Examination.

    Time frame: Until 2 weeks before RT

    Assessment of cognitive function in patients with brain metastases by Mini-Mental State Examination. It is scored from 0 to 30. Higher scores mean better outcome.

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Naples

Other

Registry information

Official study title

MAnagement of METastatic Disease in Campania (MAMETIC): Role of Radiotherapy in an Italian Region: Protocol for an Observational Multicenter Trial

Acronym: MAMETIC

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 20, 2020
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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